Package leaflet: Information for the user
3 mg/g cream
Alprostadil
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or phamacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What VITAROS is and what it is used for
2. What you need to know before you use VITAROS
3. How to use VITAROS
4. Possible side effects
5. How to store VITAROS
6. Contents of the pack and other information
1. What Vitaros is and what it is used for
Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in
100 mg of cream.Vitaros is used to treat erectile dysfunction (ED) in men 18 years
of age or older. ED is the inability to attain or maintain an erection sufficient for
sexual intercourse. There are several causes of ED including medications that you
may be taking for other conditions, poor blood circulation in the penis, nerve
damage, emotional problems, too much smoking or alcohol use, and hormonal
problems. Often ED is due to more than one cause. Treatments for ED include
switching medications, if you are taking a medication that causes ED, prescription
medications, medical devices that produce an erection, surgical procedures to
correct blood flow to the penis, penile implants and psychological counseling. After
application of Vitaros the onset of erection is within 5 to 30 minutes. You should
not stop taking any prescription medications, unless told to do so by your doctor.
2. What you need to know before you use Vitaros
Do not use Vitaros
- if you have underlying disorders such as drop in blood pressure when going from
a lying/sitting to a standing position, history of a heart attack, and syncope
(dizziness)
- if you are allergic to alprostadil or any of the other ingredients of this medicine
(listed in section 6).
- if you have a condition that might result in a long-lasting erection or a condition
such as sickle cell anaemia or trait, thrombocythemia, polycythemia, multiple
myeloma, or leukaemia
- if you have an abnormally formed penis
- if you have an inflammation or infection of the penis
- if you are prone to a venous thrombosis
- if you have a hyperviscosity syndrome which could result in a long-lasting
erection
- if you have been told not to have sex for health reasons such as heart problems
or a recent stroke
- if your partner is pregnant, breast feeding or of childbearing potential unless
you use a condom barrier.
Warnings and precautions
Talk to your doctor or pharmacist before using Vitaros if you have a history of the
following local effects that have been observed with the use of Vitaros:
- prolonged erections lasting >4 hours (priapism)
- symptomatic hypotension (dizziness)
- hepatic and/or renal insufficiency- a lowered dose due to impaired metabolism
may be required
- fainting
A condom should be used in the following situations:
- your partner is pregnant or breastfeeding
- your partner is of childbearing potential
- to prevent sexually transmitted diseases
- during oral sex and anal sex
Only latex condoms have been studied. It is not known if condoms made of other
materials may be damaged.
Other medicines and Vitaros
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The use of Vitaros with other drugs used to treat Erectile Dysfunction have not been
studied. Therefore, if you are taking other drugs for ED, do not combine with Vitaros
as there could be signs including dizziness, fainting and prolonged erections.
Vitaros has not been tested for use with penile implants or smooth muscle relaxants
such as papaverine; drugs used to induce erections such as alpha blocking drugs
(e.g. intracavernosal phentolamine, thymoxamine). There is a risk of priapism
(painful prolonged abnormal erection) when used in combination.
Although not studied, it is possible that Vitaros may have less of an effect when
taken in combination with treatments for high blood pressure, decongestants and
appetite suppressants.
If you are taking drugs to prevent blood clots, do not take Vitaros as there may be
an increased risk for bleeding or blood found in the urine.
In combination with high blood pressure medication, Vitaros use may increase
symptoms of dizziness and fainting, especially in the elderly.
Pregnancy, breast-feeding and fertility
There are no data on the use of Vitaros in pregnant women. Pregnant women
should not be exposed to Vitaros.
It is not recommended to use Vitaros while breastfeeding.
It is not known whether Vitaros has an effect on human male fertility.
Driving and using machines
Vitaros may make you feel dizzy or faint. Do not drive or operate machinery within
1 to 2 hours after administration.
3. How to use Vitaros
Always use this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Vitaros is available in two dosage strengths of 200 and 300 mcg alprostadil in
100 mg of cream. Vitaros should be used as needed to achieve an erection. Each
Vitaros AccuDose™ container is for single use only and should be properly discarded
after use.
For an erection: the starting dose should be recommended by a physician.
Do not adjust your dose yourself. Talk to your doctor who will instruct you on
proper technique for administration and accomodation of your dose.
Do not apply Vitaros more than 2-3 times a week and only once per 24 hour
period.
The onset of effect is within 5 to 30 minutes after administration. The duration of
effect is approximately 1 to 2 hours. But, the actual duration can vary from patient
to patient.
Apply Vitaros to the tip of the penis within 5 to 30 minutes prior to attempting
intercourse by following the instructions below:
1. Wash your hands before applying Vitaros. Remove the AccuDose™ container
from the foil pouch by tearing fully down the seal from the middle of the top
edge. Remove the AccuDose™ container from the sachet. Save the sachet for
discarding the used AccuDose™ container later. Remove the cap from the tip
of the container. (Figure 1)
Plunger
Barrel
Tip
Protective Cap
Figure 1
2. Grasp the tip of the penis with one hand and gently manipulate to widen the
opening of the penis. Note: if you are not circumcised, first retract and hold the
foreskin back prior to widening the opening of the penis. (Figure 2)
Figure 2
3. Hold the barrel of the AccuDose™ container between your fingers and place the tip
of the container over the opening of the penis and carefully push down the plunger
with your thumb or finger until all the cream is expelled from the AccuDose™
container barrel into the opening and surrounding skin (Figure 3). Note: do not
insert the tip of the AccuDose™ container into the opening of the penis.
Figure 3
4. Hold the penis in an upright position for approximately 30 seconds to allow
the cream to penetrate. There will likely be some cream that does not fit into
the opening of the penis. The amount of extra cream will vary depending on the
it isinnot
that half for
of the
dose will remain
at the to
edge
of
4. patient
Hold theand
penis
an unusual
upright position
approximately
30 seconds
allow
the
not use There
a second
to compensate
for cream
the opening.
cream to Do
penetrate.
willAccuDose™
likely be some
cream that does
not fit not
into
expelled
intoof
the
opening
of the
penis.ofAny
excess
cream
the opening
the opening
the
penis. The
amount
extra
cream
will covering
vary depending
on the
may
be and
rubbed
into the
opening
skin surrounding
thethe
application
patient
it is gently
not unusual
that
half of and
the dose
will remain at
edge of site
with
the tip ofDo
a finger.
the opening.
not use a second AccuDose™ to compensate for cream not
5. expelled
Remember
each
dose
is good
forAny
a single
only.
into
theVitaros
opening
of the
penis.
excessadministration
cream covering
theReplace
opening
the
on the AccuDose™
container
and
place
the openedthe
foilapplication
sachet, fold
maycap
be rubbed
gently into the
opening
and
skin in
surrounding
site
and discard
with local requirements.
with
the tip in
of accordance
a finger.
6.
mayeach
be irritating
to theis eyes.
your hands
after applying
5. Vitaros
Remember
Vitaros dose
goodWash
for a single
administration
only.Vitaros.
Replace
the cap
onadolescents
the AccuDose™ container and place in the opened foil sachet, fold
Children
and
and isdiscard
in accordance
with local
requirements.
Vitaros
not indicated
for children
or men
below 18 years of age.
6. Vitaros may be irritating to the eyes. Wash your hands after applying Vitaros.
If you use more VITAROS than you should
Children
Overdoseand
withadolescents
Vitaros requiring treatment has not been reported. Overdose with
Vitaros
is
not
indicated
for children
men below
18 years
of age.persistent pain in
Vitaros may result
in a drop
in bloodorpressure,
fainting,
dizziness,
the
penis,
and
possible
prolonged
erection
lasting
longer
than
4 hours. This can
If you use more VITAROS than you should
result
in
permanent
worsening
of
erectile
function.
Call
your
doctor
promptly
if
Overdose with Vitaros requiring treatment has not been reported. Overdose
with
you
suffer
anyinof
theseineffects.
Vitaros
maywith
result
a drop
blood pressure, fainting, dizziness, persistent pain in
If
you
haveand
anypossible
further questions
the uselasting
of thislonger
medicine,
your doctor
or
the
penis,
prolongedon
erection
thanask
4 hours.
This can
pharmacist.
result
in permanent worsening of erectile function. Call your doctor promptly if
you
suffer with
of these effects.
4. Possible
sideany
effects
If
you
any further
questions
on the
of thisalthough
medicine,
your doctor
Like
allhave
medicines,
VITAROS
can cause
sideuse
effects,
notask
everybody
getsor
them.
pharmacist.
If you get a long-lasting erection of more than 4 hours, contact your doctor immediately.
4.
YourPossible
doctor side
may effects
reduce your dose of Vitaros or discontinue your treatment.
Like all medicines, VITAROS can cause side effects, although not everybody gets them.
Common side effects (may affect more than 1 in 10 patients):
If
you get a long-lasting erection of more than 4 hours, contact your doctor immediately.
You:
Your
doctor
may reduce
your
dose burning
of Vitaros
discontinue
your
- mild
to moderate
local
aching,
oror
pain
and redness
oftreatment.
the penis
- rash side effects (may affect more than 1 in 10 patients):
Common
-You:genital pruritus
penile
- mild
tooedema
moderate local aching, burning or pain and redness of the penis
inflammation of the glans penis (balanitis)
- rash
penile tingling,
- genital
pruritus throbbing, numbness, burning
Your
partner:
- penile
oedema
mild vaginal burning
or itching,
- inflammation
of the glans
penis vaginitis
(balanitis)
-Thispenile
tingling,
throbbing,
numbness,
burning
effect may be due to the drug or to the
act of vaginal penetration. Using a
Your
partner:lubricant can help to make vaginal penetration easier.
water-based
-Uncommon
mild vaginal
or itching,
vaginitis
but burning
potentially
serious side
effects (may affect up to 1 in 100 patients):
This
effect
may
be
due
to
the
drug
or
to the act of vaginal penetration. Using a
You:
water-based
lubricant can help to make vaginal penetration easier.
- light-headedness/dizziness
- prolonged
erection
for more
than
4 effects
hours (may affect up to 1 in 100 patients):
Uncommon
but
potentially
serious
side
- fainting
You:
- low
blood pressure or rapid pulse
light-headedness/dizziness
- pain
at the erection
application
orthan
in extremity
prolonged
for site
more
4 hours
urethral stenosis
- fainting
increase
sensitivity
- low
bloodinpressure
or rapid pulse
- penile
pain atitching
the application site or in extremity
genital rash
- urethral
stenosis
scrotal pain
- increase
in sensitivity
- fullness
in genitals
penile itching
lack of sensation
to penis
- genital
rash
urinary pain
tract inflammation
- scrotal
partner:
-Your
fullness
in genitals
vulvovaginal
pruritus
- lack
of sensation
to penis
sexual/physical
activity in combination with Vitaros may increase the
-*Increased
urinary tract
inflammation
risk
heart attack or stroke in patients with underlying disease/risk factors
Yourofpartner:
(see
Section 2). pruritus
- vulvovaginal
If
any of the side
effects gets serious,
or in
if you
notice any side
effects
notmay
listedincrease
in this leaflet,
*Increased
sexual/physical
activity
combination
with
Vitaros
the
please
tell
your
doctor
or
pharmacist.
risk of heart attack or stroke in patients with underlying disease/risk factors
(see
Section
2). effects:
Duration
of side
If
any of
the side
effects
serious,
if you notice
any1-2
sidehours
effects not listed in this leaflet,
Most
effects
are
shortgets
acting
andorresolve
within
please tell your doctor or pharmacist.
Reporting of side effects
Duration
side
If you get of
any
sideeffects:
effects, talk to your doctor. This includes
Most
effects side
are short
acting
and resolve
within 1-2
any possible
effects
not listed
in this leaflet.
Alsohours
you can help to make sure
that
medicines
remain
as safe as possible by reporting any unwanted side effects via
Reporting
of side
effects
the
internet
www.mhra.gov.uk/yellowcard
. Alternatively
you can call Freephone
If you
get anyatside
effects, talk to your doctor.
This includes
0808
100 3352
from
10ina.m.
2 p.m.Also
Mondays
tohelp
Fridays)
or fillsure
in a
any
possible
side (available
effects not
listed
thisto
leaflet.
you can
to make
paper
form available
from
youraslocal
pharmacy.
By reporting
side effects
can via
that medicines
remain
as safe
possible
by reporting
any unwanted
sideyou
effects
helpinternet
provideat
more
information
on
the
safety
of
this
medicine.
the
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
5. How
to3352
store(available
Vitaros from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a
0808
100
paper
form
availableout
from
yoursight
localand
pharmacy.
reporting side effects you can
Keep this
medicine
of the
reach ofBy
children.
help
provide
more information
on the
safety
of this
medicine.
Do not
use VITAROS
after the expiry
date
which
is stated
on the carton, sachet and
AccuDose™
container
label
after
Exp.
5. How to store Vitaros
The expiry
date refers
dayand
of the
month.
Keep
this medicine
outtoofthe
thelast
sight
reach
of children.
Store
a refrigerator
(2°Cthe
- 8°C).
Do
notinuse
VITAROS after
expiry date which is stated on the carton, sachet and
Do
not freeze.
AccuDose™
container label after Exp.
Unopened
sachets
maytobe
kept
by the patient, at a
The
expiry date
refers
the
lastout
dayofofthe
therefrigerator
month.
temperature
below 25°C
up to 3 days prior to use.
Store in a refrigerator
(2°Cfor
- 8°C).
At
of this period, the product should be discarded if not used.
Dothe
notend
freeze.
Each
dispenser
is for
single
use only.
Unopened
sachets
may
be kept
out of the refrigerator by the patient, at a
Once
opened,
use
immediately,
any
unused
portion.
temperature below 25°C for up discard
to 3 days
prior
to use.
Store
theoforiginal
sachet
in product
order toshould
protectbefrom
light. if not used.
At theinend
this period,
the
discarded
Each dispenser is for single use only.
Once opened, use immediately, discard any unused portion.
Store in the original sachet in order to protect from light.
CW2051-2.indd 2
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist to throw away medicines you no longer use. These measures will help
protect the environment.
6.
the any
packmedicines
and othervia
information
Do Contents
not throwof
away
wastewater or household waste. Ask your
pharmacist
to throw
away medicines you no longer use. These measures will help
What
VITAROS
contains
protect
thesubstance
environment.
The
active
is Alprostadil
Each
single container
contains
300 micrograms
6. Contents
of the pack
and other
informationof alprostadil in 100 mg of cream
(3mg/g).
What VITAROS contains
Vitaros
is available
in unit
cartons with four (4) single dose containers.
The active
substance
is Alprostadil
The
are purified
ethanol,
laurate;
Eachother
singleingredients
container contains
300water;
micrograms
ofanhydrous;
alprostadil ethyl
in 100
mg of cream
hydroxypropyl
guar gum; dodecyl-2-N,N-dimethylaminopropionate hydrochloride;
(3mg/g).
potassium
dihydrogen
phosphate;
sodium
for pHcontainers.
adjustment; phosphoric
Vitaros is available
in unit
cartons with
fourhydroxide,
(4) single dose
acid,
for pH
adjustment.
The other
ingredients
are purified water; ethanol, anhydrous; ethyl laurate;
hydroxypropyl
dodecyl-2-N,N-dimethylaminopropionate
hydrochloride;
What
VITAROSguar
looksgum;
like and
contents of the pack
potassium
phosphate;
sodium
hydroxide,
for pH adjustment;
Vitaros
is a dihydrogen
white to off-white
cream
supplied
in AccuDose™,
a single dosephosphoric
container.
acid, for pH adjustment.
AccuDose™
is a container consisting of a plunger, barrel, and protective cap.
Each
is provided
in acontents
protective
Whatcontainer
VITAROS looks
like and
of sachet.
the pack
The
sachets
are composed
of cream
aluminium
foil/laminate.
The container
components
Vitaros
is a white
to off-white
supplied
in AccuDose™,
a single dose
container.
are
composed
polypropylene
and polyethylene.
AccuDose™
is aofcontainer
consisting
of a plunger, barrel, and protective cap.
Each container
is providedHolder
in a protective sachet.
Marketing
Authorisation
The
sachets
are
composed
of aluminium foil/laminate. The container components
Ferring
Pharmaceuticals
Ltd
Takeda UK Ltd
are
composed
of polypropylene and polyethylene.
Drayton
Hall
Building
3
Glory
Park
Church
Road
Marketing
Authorisation Holder
Glory
Park
West
Drayton
Ferring
Pharmaceuticals
Ltd
Takeda
UK Avenue
Ltd
Wooburn
UB7
7PSHall
Drayton
Building
3Green
BUCKS
UnitedPark
Kingdom
Glory
Church
Road
HP10
0DF Avenue
Glory
Park
West
Drayton
PL 03194/0125
United
Kingdom
Wooburn
UB7 7PS Green
Manufacturer
BUCKS
United Kingdom
HP10 0DF
Takeda
UK Ltd
PL 03194/0125
United
Kingdom
Building
3
Glory
Park
Manufacturer
Manufacturer
Glory
Park
Ferring
GmbH
Takeda
UK Avenue
Ltd
Wooburn
Green
Building 3
Wittland
11
BUCKS
Glory Park
24109
Kiel
HP10
0DF Avenue
Glory Park
Germany
United
Kingdom
Wooburn
Green
This
medicinal product is authorised in the Member States of the EEA under the
BUCKS
following
HP10 0DF names:
United Kingdom
Vitaros
3mg/g cream
This
medicinal
is authorised
in thename
Member States of the EEA under the
Member
Stateproduct Proposed
product
following
Germany names:
Vitaros® HEXAL® 300 Mikrogramm/100 mg Creme
Vitaros
3mg/g cream Vitaros 3 mg/g cream
UK
Member State
Proposed
product
name
France
Vitaros
300
microgrammes,
crème
®
Germany
Vitaros®3 HEXAL
300 Mikrogramm/100 mg Creme
Spain
Virirec
mg/g Crema
UK
Vitaros 3 mg/g cream
Sweden
Kräm
France
Vitaros 300
microgrammes,
crème
Ireland
3 mg/g
Cream
Spain
Virirec
Belgium
Vytaros33mg/g
mg/gCrema
crème
Sweden
Vitaros
Luxembourg
Vytaros 33 mg/g
mg/g Kräm
crème
Ireland
Vitaros 3
mg/g
Cream crème
Netherlands
300
microgram
Belgium
Vytaros
3 mg/g crème
This
November
2016.
This
leaflet was last revised
revised
in 09/2014.
06/2016
This
leaflet
in
Luxembourg
Vytaros 3 mg/g crème
Other Sources of Information
Netherlands
Vitaros 300 microgram crème
Detailed information on this medicine is available on the Medicines and Healthcare
This leaflet
leaflet
was last revised
revised in
in 09/2014.
06/2016
This
products
Regulatory
Agency
(MHRA)
web site: http://www.mhra.gov.uk.
Other Sources
Information
EFFECTS
AFTER of
APPLICATION:
Detailedrequires
information
on this
is available
the Medicines
andcan
Healthcare
Vitaros
between
5 tomedicine
30 minutes
to beginon
working
before you
have
products
RegulatoryAfter
Agency
(MHRA) webyou
site:
http://www.mhra.gov.uk.
sexual
intercourse.
administration
can
engage in foreplay, which helps
arousal
the APPLICATION:
process of developing an erection. An effective dose of Vitaros
EFFECTSand
AFTER
should
erection
sufficient
for sexual
intercourse.
The duration
the
Vitaros produce
requires an
between
5 to
30 minutes
to begin
working before
you canofhave
effect
is
approximately
1
to
2
hours.
However,
the
actual
duration
will
vary
from
sexual intercourse. After administration you can engage in foreplay, which helps
patient
to patient
and the
of the drug.
VitarosAn
may
not create
arousal and
the process
of dose
developing
an erection.
effective
dosean
oferection
Vitaros
comparable
to
those
you
experienced
when
you
were
younger.
Some
patients
may
should produce an erection sufficient for sexual intercourse. The duration
of the
experience
some mild pain,
sensation,
and
aching
in the will
penis
or from
groin
effect is approximately
1 to a
2 burning
hours. However,
the
actual
duration
vary
area.
Also,
your erection
may
continue
for a time
after
orgasm
or ejaculation.
After
patient
to patient
and the
dose
of the drug.
Vitaros
may
not create
an erection
your
erectiontoisthose
over your
penis may feel
full,you
warm,
and
somewhat
sensitive
tomay
comparable
you experienced
when
were
younger.
Some
patients
touch.
These
effects
are
normal
and may
last for aand
fewaching
hours.in the penis or groin
experience
some
mild
pain,
a burning
sensation,
ADDITIONAL
INFORMATION
PRACTICAL
TIPS:after orgasm or ejaculation. After
area. Also, your
erection mayAND
continue
for a time
yourand
erection
is over will
yourdetermine
penis maythe
feelappropriate
full, warm, dose
and somewhat
to
You
your doctor
of Vitaros. sensitive
If your erection
touch. These
effects are
and
may last
a few
hours.
cannot
be maintained
fornormal
the time
needed
to for
have
foreplay
and sexual intercourse,
you
may needINFORMATION
to have your dose
Similarly,
ADDITIONAL
ANDincreased.
PRACTICAL
TIPS: if an erection lasts longer than
desired
if the
side effects
are not the
wellappropriate
tolerated you
may
your
reduced.
You andor
your
doctor
will determine
dose
ofneed
Vitaros.
If dose
your erection
Call
your
doctor
if
you
suspect
that
you
may
require
an
adjustment
of
your
dose.
cannot be maintained for the time needed to have foreplay and sexual intercourse,
Factors
enhance
you maythat
needmay
to have
your your
dose erection:
increased. Similarly, if an erection lasts longer than
orwell
if the
side effects are not well tolerated you may need your dose reduced.
-desired
being
rested.
your doctor
if you
that you
may require an adjustment
-Callsexual
foreplay
withsuspect
your partner
or self-stimulation
while sittingoforyour
lyingdose.
after
application
of
Vitaros.
Factors that may enhance your erection:
-- pelvic
exercises
such as tightening and releasing your pelvic and buttock
being well
rested.
muscles.
These with
are the
muscles
you
to stop urination.
- sexual
foreplay
your
partner
or use
self-stimulation
while sitting or lying after
- various
positions
that
may
favour
and
not
restrict blood flow to the penis.
application of Vitaros.
- pelvic
exercises
as your
tightening
and releasing your pelvic and buttock
Factors
which
may such
reduce
erection:
muscles.fatigue,
These are
the muscles
use alcohol.
to stop urination.
- anxiety,
tension,
and tooyou
much
positions
that may
and not
restrict
to the penis.
-- various
urination
immediately
afterfavour
application
may
result blood
in lossflow
of medication.
IN-CW2051-2
CW2051-2
Factors which may reduce your erection:
- anxiety, fatigue, tension, and too much alcohol.
- urination immediately after application may result in loss of medication.
IN-CW2051-2
CW2051-2
2014/08/11 3:11 PM